Chronic Pediatric Skin ConditionsNCT03544866
The Impact of Pediatric Skin Disorders: The "Big" Study
An observational study of Chronic Pediatric Skin Conditions, run by Northwestern University at 1 site in United States.
Trial summary
This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Chronic Pediatric Skin Conditions
- How many people
- 1,666 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2018to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).
Who may be able to join
- Subjects must be aged 8-17 years of age
- Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
- Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
- Subject and Parent/Guardian must be able to complete the relevant questionnaires
Who cannot join
- Children under 8 years of age
- Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
- Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology, Northwestern University Feinberg School of Medicine and Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.
Read the detailed description
This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.
- Conditions
- Chronic Pediatric Skin Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
Measured: Past 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start16 Nov 2018
- Primary completion31 May 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pediatric Skin ConditionsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Dermatology Research Alliancce, Regeneron Pharmaceuticals, Immunex Corporation
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544866
- Sponsor's protocol ID
- ASP02172016
- Status last verified
- Apr 2022
- First submitted
- 22 May 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pediatric Skin Disorders: The "Big" Study
- ClinicalTrials.gov ID
- NCT03544866
- Acronym / sponsor ID
- ASP02172016
- Conditions
- Chronic Pediatric Skin Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,666 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Pediatric Dermatology Research Alliancce, Regeneron Pharmaceuticals, Immunex Corporation
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study leverages the availability of a validated series of instruments to measure the effect of highly visible, chronic skin disorders, including atopic dermatitis (AD), on patients 8 years of age and above in causing stigma and psychiatric issues, particularly anxiety and depression.
Detailed description
This is a multi center study with Northwestern University/Lurie Children's Hospital serving as the Data Coordinating Center. Site selection has been completed through members of PeDRA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 3,500 parent/child dyads across all sites (at least 50 parent/child dyads at each site).
Key inclusion criteria (4 listed)
- Subjects must be aged 8-17 years of age
- Subject must be diagnosed with a chronic skin disease deemed to be severe enough and/or in a visible location that could be stigmatizing as determined by the study doctor
- Subject and parent must both be English speaking with at least one parent/guardian who will complete the questionnaires
- Subject and Parent/Guardian must be able to complete the relevant questionnaires
Key exclusion criteria (3 listed)
- Children under 8 years of age
- Children with developmental delay and/or a behavioral disorder that would preclude participation in form completion
- Children with a non-cutaneous disorder that is considered by the Study doctor to be stigmatizing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
Time frame: Past 7 days
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pediatric Skin Conditions, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the stigma experienced by children as a function of the child's perceived skin lesion visibility using the altered Neuro-QoL stigma tool (time frame: Past 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.